medical Class II Updated 2020-06-10

Nobel Biocare Usa Llc recalls NobelActive Internal NP 3.5x15mm Endosseus dental implant, R

Recalled Product

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

Hazard / Issue

The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI
Lot/Code Info: Lot number: 13080792
View official government recall

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